ENCePP Guide on Methodological Standards in Pharmacoepidemiology

8. Dissemination and reporting

8.1. Principles of communication

Aspects of research communication and reporting include, but are not limited to, reports to health authorities, sponsors, presentations in scientific fora, scientific publications, patient focused communications and websites.

The Declaration of Helsinki provides guidance on the registration, publication and dissemination of research results. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject. A means to achieve this with pharmacoepidemiology studies is through registration of protocols and reports of studies in the EU PAS Register.

8.2. Communication of study results

Important points that are emphasised by the guidelines cited below are:

Sources of research funding should always be disclosed whether in oral or written presentation.

A dissemination and communication strategy should be pre-defined as part of the funding contract.

All results with a scientific or public health impact must be made publicly available without undue delay.

Quantitative measures of association should be reported rather than just results of testing.

The STROBE statement is designed to apply to all observational studies. In addition, The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement (PLoS Med. 2015;12(10):e1001885) was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD makes additional recommendations on the reporting of methods of selection for study populations, exposures, outcomes and covariates (including codes or algorithms used), whether validation has been conducted, the level of access to databases used, and data linkages that were required to conduct the study.

The Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Statement is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses consisting of a 27-item checklist and a flow diagram. While focused on randomised trials, PRISMA can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions. PRISMA may also be useful for critical appraisal of published systematic reviews, although it is not designed as a quality assessment instrument.

The Guidelines for Submitting Adverse Event Reports for Publication (Pharmacoepidemiol Drug Saf 2007;16(5): 581–7) lists the key elements that have to be included when publishing a report of one or more adverse events. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) andare available on their web sites.